SN EN ISO 8871-2 : 2005 AMD 1 2014

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)

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Superseded date: 10-09-2021

Language(s):

Published date: 12-01-2013

Publisher: Swiss Standards

Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Tests
4 Preparation of samples for testing
5 Reagents and materials
Annex A (informative) Identification of elastomeric material
                      by pyrolysis IR
Annex B (informative) Determination of compression set
Annex C (informative) Swelling behaviour in oils
Annex D (informative) Development of a fingerprint by gas
                      chromatography
Annex E (informative) Analysis of volatile components by
                      headspace gas chromatography
Annex F (informative) Determination of residual moisture
Annex G (informative) Determination of a fingerprint by
                      thermal gravimetry (TG)
Bibliography

Abstract - (Show below) - (Hide below)

Provides evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies.

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Committee	INB/NK 2205
Development Note	Supersedes SNV NF EN ISO 8871 (04/2005) Supersedes SNV NF S93-102. (10/2006)
Document Type	Standard
ISBN
Pages
Published
Publisher	Swiss Standards
Status	Superseded
Superseded By	SN EN ISO 8871-2:2020
Supersedes	SNV NF EN ISO 8871 : 1997 SNV NF S93-102 : 1997

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DIN EN ISO 8871-2:2014-08	Identical
NS EN ISO 8871-2 : 2004 AMD 1 2014	Identical
I.S. EN ISO 8871-2:2004	Identical
NF EN ISO 8871-2 : 2005 AMD 1 2014	Identical
UNI EN ISO 8871-2 : 2014	Identical
EN ISO 8871-2:2004/A1:2014	Identical
NEN EN ISO 8871-2 : 2004 AMD 1 2014	Identical
ISO 8871-2:2003	Identical
NBN EN ISO 8871-2 : 2004 AMD 1 2014	Identical
BS EN ISO 8871-2 : 2004	Identical
UNE-EN ISO 8871-2:2005	Identical
ONORM EN ISO 8871-2 : 2014	Identical

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